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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH

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BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH Back to Search Results
Model Number M004CRBS3050
Device Problem Leak/Splash (1354)
Patient Problem Non specific EKG/ECG Changes (1817)
Event Date 11/15/2021
Event Type  Injury  
Event Description
It was reported that during a cryoablation involving a polarx catheter and polarsheath. During preparation outside the patient the light blue cap of the first polarsheath handle became detached, and was therefore replaced prior to insertion into the body. During the procedure with the second polarsheath. After inserting the polarx catheter into the sheath, the physician tried to remove the air by pulling the syringe attached to the side port, and noticed that the action induced air. The physician noticed a st segment elevation and a shadow in left atrium 16 minutes after transseptal procedure. The second polarsheath sheath was then also exchanged. At that time, the outer balloon pressure (obp) value increased all throughout. After cooling the left superior pulmonary vein, the pressure continued to increase and an error (1-00000020-2 outer balloon pressure too high) occurred. The cryo cable were disconnected then reconnected, however, the pressure remained high. The cable was exchanged twice and the catheter was also exchanged. During the new catheter preparation, its obp value kept increasing and reconnection didn't resolve the issue. The catheter was exchanged again for catheter of another model, then the obp value stabilized. The procedure was completed with no additional complications. This product is part of the (b)(4) advisory population for the polarsheath steerable sheath.
 
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Brand NamePOLARSHEATH
Manufacturer (Section D)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
302 parkway
global park, la aurora
heredia
CS
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
302 parkway, global park
la aurora - heredia
CS
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key13006811
MDR Text Key282324804
Report Number2134265-2021-15724
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup
Report Date 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM004CRBS3050
Device Lot Number0027634031
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown
Removal/Correction Number92688876-FA

Patient Treatment Data
Date Received: 12/14/2021 Patient Sequence Number: 1
Treatment
POLARX BALLOON CATHETER; SMARTFREEZE CONSOLE; SMARTFREEZE CRYO CABLE
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